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510(k) K990665

BQ/BM INTEGRATED LASER DELIVERY SYSTEM by American Laser Corp. — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1999
Date Received
March 2, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Ophthalmic
Device Class
Class II
Regulation Number
886.4390
Review Panel
OP
Submission Type

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  • K813429 — LASER PHOTOCOAGULATOR ARGON MED. LASER (January 22, 1982)

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